LONDON (Reuters)—U.S. drug approvals hit a 21-year high in 2017, with 46 novel medicines winning a green light—more than double the previous year—while the figure also rose in the European Union. The European Union (EU) recommended 92 new drugs, including generics, up from 81; and China laid out plans to speed up approvals in what…
Etanercept’s New Autoinjection System; Plus FDA Approves Ixekizumab for Active PsA
In the U.S., a new formulation and an ergonomic delivery system for single doses of etanercept are now available for RA patients…
Limbrel Linked to Possible Fatal Adverse Events
The FDA is investigating serious and potentially fatal side effects associated with Limbrel, which is designed to manage metabolic processes in patients with osteoarthritis…
U.S. Approves Digital Pill that Tracks When Patients Take It
(Reuters)—U.S. regulators have approved the first digital pill with an embedded sensor to track if patients are taking their medication properly, marking a significant step forward in the convergence of healthcare and technology.1 The medicine is a version of Otsuka Pharmaceutical Co Ltd’s established drug Abilify for schizophrenia, bipolar disorder and depression, containing a tracking…
Ustekinumab Approved for Use in Adolescents with Plaque Psoriasis
In October, the FDA approved ustekinumab to treat patients 12 years or older who have moderate to severe plaque psoriasis…
FDA Sets Stricter Requirements for Immediate-Release Opioids to Prevent Misuse & Abuse
The FDA is expanding its Risk Evaluation and Mitigation Strategy (REMS) to include manufacturers of immediate-release opioids. The makers of these drugs will soon be required to provide training and education to healthcare professionals on the proper prescription and use of the drugs for pain management…
U.S. to Promote Use of Opioid Alternatives to Treat Addiction
(Reuters)—The U.S. Food and Drug Administration plans to encourage opioid addicts to use less harmful opioid drugs such as methadone and buprenorphine, a radical shift in policy that could agitate those in the addiction field who believe abstinence is the only effective treatment. Speaking before the House Committee on Energy and Commerce on Wednesday, FDA…
Supplemental Application for Denosumab Goes to FDA
The FDA accepted for review a supplemental biologics license application for denosumab to treat patients with glucocorticoid-induced osteoporosis…
GSK Wins U.S. Shingles Vaccine Approval, U.K. Nod for Gene Therapy
LONDON (Reuters)—GlaxoSmithKline has won U.S. approval for a new and improved shingles vaccine, the second of three key products for which the British drugmaker expects approval this year. It also secured a recommendation from U.K. cost authorities for a $700,000 gene therapy for so-called “bubble boy” disease—a step forward for the field of fixing faulty…
Efficacy Studied Following Accelerated Drug Approvals
In recent years, the number of drugs to receive accelerated FDA approval has increased. A new study examined whether these drugs have demonstrated efficacy in post-approval trials…